Recon: FDA says Lilly’s tirzepatide shortage is resolved; Merck’s HIV therapy achieves success in pair of Phase 3 trials
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- FDA confirms shortage of weight loss drug tirzepatide is over, gives compounders a grace period (STAT)
- Muscle dysmorphia in boys and men is on the rise, fueled by social media (STAT)
- What biotech could bring in 2025 (STAT)
- Copy-pasted notes and untrained providers: First federal audit of autism therapy finds problems in every record (STAT)
- The health care deal is in jeopardy (STAT)
- US FDA declines to approve Zealand Pharma's bowel disease drug (Reuters)
- Merck's HIV treatment meets main goal in two late-stage studies (Reuters)
- ‘Research that’s desperately needed’: White House conference spotlights women’s health (MedTech Dive)
- Rare, Pediatric Drug Development and Reimbursement Boosted In Shaky US Spending Deal (Pink Sheet)
- Kennedy ticks off easy wins in US Senate tour, tougher meetings on top health job ahead (Reuters)
- Eli Lilly's Alzheimer's treatment approved in China (Reuters)
- The DRC ‘mystery illness’ shows why the U.S. can’t ‘pause’ infectious disease work (STAT)
- Lonza expands capsule footprint; BioCentriq's new HQ (Endpoints)
- German Medtechs Urge Incoming Government To Be More Collaborative (MedTech Insight)
- Alexion Cautions Against Reduction In EU Orphan Drug Incentives (Pink Sheet)
- After two rejections, FDA approves Mesoblast's first-of-its-kind cell therapy (Fierce Pharma)
- Biotech stocks hammered after Fed rate projections (STAT)
- Vertex touts pain drug results, but medicine does not outperform placebo in sciatica study (STAT)
- The Endpoints 2024 winners and losers list: Who was up and who was down in biopharma (Endpoints)
- Exclusive: Can oral antibodies work? A small startup thinks it has an answer (Endpoints)
- Updated: Flagship gene therapy startup Ring Therapeutics nearly halves workforce as CEO departs (Endpoints)
- What health tech startups can expect in 2025 (Endpoints)
- Gilead deepens its stake in Assembly Biosciences; NGM licenses out MASH drug (Endpoints)
- Novartis says 330 jobs hit as it closes MorphoSys sites (Reuters)
- Medline sets stage for blockbuster US IPO with confidential filing (Reuters)
- Playing catch-up with Pfizer and Roche, China-made ALK drug clears FDA in lung cancer (Fierce Pharma)
- Klick Health goes on a hiring spree to close out the year, adding 22 new leaders (Fierce Pharma)
- Analysts tip BMS’ Cobenfy to be top dog in growing schizophrenia market (Fierce Pharma)
- Gene Therapy Follow-Up: Balance Data Needs And Patient Burden, Bluebird Bio Exec Says (Pink Sheet)
- These challenges could delay brain-computer interfaces from becoming a reality for patients (STAT)
- Boston Scientific updates cryoablation catheter instructions after 4 death reports (MedTech Dive)
- Medical device recalls under the spotlight in 2024 (MedTech Dive)
- Dexcom Participates In ŌURA $200M Series D Funding Round (MedTech Insight)
- Feds accuse CVS of filling ‘thousands’ of illicit opioid prescriptions (STAT)
- Health plan formularies lowered barriers to fair access to some drugs, analysis finds (STAT)
- 2025 forecast: The government crackdown on pharmas' direct-to-consumer outreach marches on (Fierce Pharma)
- Pharma's reputation is stable-ish. Will that survive Trump 2.0? (Fierce Pharma)
- Chink In PBM Armor? ‘Delinking’ Policy In Spending Bill But Passage Unclear (Pink Sheet)
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